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Assess the Safety, Tolerability, and Pharmacokinetics of HL-1186 in Healthy Participants

Assess the Safety, Tolerability, and Pharmacokinetics of HL-1186 in Healthy Participants

Recruiting
18-45 years
All
Phase 1

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Overview

This single-center, randomized, double-blind, placebo-controlled, two-part study is designed to assess the safety, tolerability and PK of oral HL-1186 Tablet in healthy participants.

Eligibility

Inclusion Criteria:

  1. Healthy participants, males and females.
  2. Between the ages of 18 and 45 years old (inclusive).
  3. Weighs no less than 50 kg (for males) or 45 kg (for females) and body mass index (BMI) within 19.0 to 26.0 kg/m2 (inclusive).
  4. During the screening period, vital signs, physical examination, blood routine, blood biochemistry, coagulation function, urine routine, virology examination, chest X-ray, and pregnancy blood test (female) were examined, and the results did not show abnormalities or abnormalities without clinical significance.

Exclusion Criteria:

  1. Females who are pregnant or breastfeeding; females/males who are prepared for having children.
  2. History or presence of neurological, cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematological, endocrine, or osteoarticular disorders, or any laboratory abnormalities that pose a potential danger to constitute a risk when taking the study intervention or interfere with the interpretation of data.
  3. Active infectious diseases which need anti-infection treatment.
  4. Significant surgery within three months and not fully recovered per investigator's judgments.
  5. Significant allergies per investigator's judgments, e.g., food allergies, allergies, or atopic reactions to any components of the investigational drug or placebo, asthma attacks, etc.
  6. Immunosuppressive diseases, e.g., immunodeficiency, etc.

Study details
    Healthy Participants

NCT06912295

Shanghai Huilun Pharmaceutical Co., Ltd.

16 April 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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